Ridge SplittingNCT06637982
Extended Platelet Rich Fibrin in Mandibular Alveolar Ridge Splitting
A study testing ridge splitting with the use of allograft and pericardium membrane and ridge splitting with the use of extended platelet rich fibrin in people with Ridge Splitting, run by Mansoura University at 1 site in Egypt.
Trial summary
Thirty two healthy implants will be selected from the outpatient clinic of the oral and maxillofacial department of Mansoura university to be included in this study for replacement of lost posterior teeth with limited bone width. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ridge Splitting
- What is being tested?
- ridge splitting with the use of allograft and pericardium membrane and ridge splitting with the use of extended platelet rich fibrin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2024to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient age 18 years old and older.
- Patient's cooperation, motivation and good oral hygiene.
- Atrophic posterior mandible of horizontal alveolar dimension range between 3 - 6 mm at the crest, with minimum 10 mm vertical height from the alveolar crest to the superior border of the inferior alveolar canal.
- Absence of undercuts in buccal aspect of the ridge.
- Favorable occlusion and no parafunctional habits.
- Patients able to comply with the required recall visits.
- No gender preface in selection of the patients.
- Acceptable inter-arch space for the future prosthesis.
Who cannot join
- Any pathological condition at the site of surgery.
- Patients with systemic diseases that contra-indicate the surgical procedure such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders, and mental disorders.
- Patient taking drugs that could affect bone healing process as immunosuppressive drugs and bisphosphonates.
- Heavy smoking and alcoholism.
- Parafunctional habits such as bruxism and clenching.
- Signs of acute infection or pus discharge.
- Untreated periodontal disease or bad oral hygiene.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extended Platelet Rich Fibrin in Mandibular Alveolar Ridge Splitting With Simultaneous Implant Placement
Thirty two healthy implants will be selected from the outpatient clinic of the oral and maxillofacial department of Mansoura university to be included in this study for replacement of lost posterior teeth with limited bone width.
- Conditions
- Ridge Splitting
- Being tested
- ridge splitting with the use of allograft and pericardium membrane, ridge splitting with the use of extended platelet rich fibrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ridge splitting with the use of allograft and pericardium membraneProcedure or surgery
ridge splitting with the use of allograft and pericardium membrane
ridge splitting with the use of extended platelet rich fibrinProcedure or surgery
ridge splitting with the use of extended platelet rich fibrin
| Study group | Role | What they receive |
|---|---|---|
| ridge splitting with allograft and pericardium membrane | Experimental | Not described Receives: Procedure: ridge splitting with the use of allograft and pericardium membrane |
| ridge splitting with extended platelet rich fibrin | Experimental | Not described Receives: Procedure: ridge splitting with the use of extended platelet rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant stability
the stability of the implants will be evaluated by RFA with the Osstell Mentor device
Measured: 9 months
alveolar ridge width
alveolar ridge width will be measured preoperative, immediate postoperative and after 9 months
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start10 Oct 2024 (estimated)
- Primary completion10 Apr 2025 (estimated)
- Study completion10 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ridge SplittingStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637982
- Sponsor's protocol ID
- A0302024OS
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Platelet Rich Fibrin in Mandibular Alveolar Ridge Splitting With Simultaneous Implant Placement
- ClinicalTrials.gov ID
- NCT06637982
- Acronym / sponsor ID
- A0302024OS
- Conditions
- Ridge Splitting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (estimated)
- Primary completion
- 10 Apr 2025 (estimated)
- Study completion
- 10 Oct 2025 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thirty two healthy implants will be selected from the outpatient clinic of the oral and maxillofacial department of Mansoura university to be included in this study for replacement of lost posterior teeth with limited bone width.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ridge splitting with allograft and pericardium membrane | Experimental | Procedure: ridge splitting with the use of allograft and pericardium membrane |
| ridge splitting with extended platelet rich fibrin | Experimental | Procedure: ridge splitting with the use of extended platelet rich fibrin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patient age 18 years old and older.
- Patient's cooperation, motivation and good oral hygiene.
- Atrophic posterior mandible of horizontal alveolar dimension range between 3 - 6 mm at the crest, with minimum 10 mm vertical height from the alveolar crest to the superior border of the inferior alveolar canal.
- Absence of undercuts in buccal aspect of the ridge.
- Favorable occlusion and no parafunctional habits.
Key exclusion criteria (7 listed)
- Any pathological condition at the site of surgery.
- Patients with systemic diseases that contra-indicate the surgical procedure such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders, and mental disorders.
- Patient taking drugs that could affect bone healing process as immunosuppressive drugs and bisphosphonates.
- Heavy smoking and alcoholism.
- Parafunctional habits such as bruxism and clenching.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ridge splitting with the use of allograft and pericardium membraneridge splitting with the use of allograft and pericardium membrane | Procedure or surgery | ridge splitting with allograft and pericardium membrane |
| ridge splitting with the use of extended platelet rich fibrinridge splitting with the use of extended platelet rich fibrin | Procedure or surgery | ridge splitting with extended platelet rich fibrin |
Primary outcome
implant stability
Time frame: 9 months
the stability of the implants will be evaluated by RFA with the Osstell Mentor device
alveolar ridge width
Time frame: 9 months
alveolar ridge width will be measured preoperative, immediate postoperative and after 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
Related trials for Ridge Splitting
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Clinical and Radiographic Evaluation of Ridge Splitting With Simultaneous Implant Placement Covered With Concentrated Growth Factor Membranes in Narrow Alveolar Ridge
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ridge splitting with the use of allograft and pericardium membrane and ridge splitting with the use of extended platelet rich fibrin in people with Ridge Splitting, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact faisal alshammri (1555250898 ext. 0020, fasialshammry@std.mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
implant stability (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.